BRAVE-HEARTHeart-Sparing Effect of Breast Radiotherapy with Active Breathing Coordinator
This observational study aims to examine the heart-sparing effect of breast radiotherapy when used in conjunction with an Active Breathing Coordinator device in breast cancer patients.
Data Collection
Breast Diseases+12
+ Breast Neoplasms
+ Cardiovascular Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: May 23, 2024
Actual date on which the first participant was enrolled.The BRAVE-HEART study focuses on breast cancer patients who are undergoing radiotherapy. This study takes place at Fondazione IRCCS Policlinico San Matteo in Italy. Its main goal is to understand how a special breathing technique, called Deep Inspiration Breath Hold (DIBH) assisted by the Active Breathing Coordinator (ABC), can help protect the heart during radiation treatment. This is particularly important for patients with stage I-III breast cancer who are typically receiving radiation therapy after surgery. The study aims to show that this special breathing technique can reduce the amount of radiation that reaches the heart and potentially improve the safety of breast cancer treatment. During the study, patients receive radiotherapy using either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated/volumetric modulated arc therapy (IMRT/VMAT) techniques. These treatments can be given in various durations and intensities, with or without a simultaneous boost to the tumor bed. The study compares the radiation dose to the heart during normal breathing and during the special breathing technique (DIBH assisted by ABC). The primary goal is to measure the reduction in radiation dose to the heart and its substructures, especially the left anterior descending coronary artery (LAD). The study also evaluates the consistency of the treatment, the feasibility of using ABC-DIBH in daily practice, and collects data on any immediate and long-term side effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Diagnosis of stage I-III breast carcinoma with an indication for radiotherapy * Invasive carcinoma or ductal carcinoma in situ (DCIS) * Radiotherapy delivered using three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated/volumetric modulated arc therapy (IMRT/VMAT) techniques * Ability to actively cooperate in using the Active Breathing Coordinator (ABC) system for Deep Inspiration Breath Hold (DIBH), or treated under free-breathing conditions when DIBH is not feasible * Age ≥18 years * Ability to provide written informed consent for the anonymous use of data for research purposes Exclusion Criteria: * Severe health problems or profound hearing loss * Severe respiratory or cardiovascular conditions in the medical history that contraindicate radiotherapy * Inability to provide written informed consent for the anonymous use of data for research purposes * Absolute contraindications to radiotherapy (e.g., pregnancy, or inability to maintain the correct treatment position)
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fondazione IRCCS Policlinico San Matteo
Pavia, ItalyOpen Fondazione IRCCS Policlinico San Matteo in Google Maps